Description

Sitagliptin Impurity 14 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for the quality control and regulatory compliance of the active pharmaceutical ingredient (API) Sitagliptin, a widely prescribed medication for type 2 diabetes. Pharmaceutical manufacturers, analytical laboratories, and research institutions require this impurity standard to ensure product safety, validate analytical methods, and meet stringent pharmacopeial requirements. Its precise characterization is essential for monitoring and controlling the manufacturing process of the API.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Sitagliptin API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, validating, and verifying HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Used to monitor the formation and levels of this specific impurity during forced degradation and long-term stability testing of Sitagliptin formulations.
• Process Chemistry Research: Aids in the study of synthetic pathways and the optimization of manufacturing processes to minimize impurity formation.
• Pharmacopoeial Testing: Employed to ensure compliance with relevant monographs in pharmacopoeias such as USP, EP, and JP.

Basic Information

Product Name	Sitagliptin Impurity 14
CAS No.	2072867-07-1
Molecular Formula	C16H15F6N5O
Molecular Weight	407.32 g/mol
Synonyms	(3R)-3-Amino-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-4-(2,4,5-trifluorophenyl)butan-1-one; Sitagliptin Related Compound 14; Januvia Impurity 14; MK-0431 Impurity 14; DPP-4 Inhibitor Impurity; 1-[[(3R)-3-Amino-4-(2,4,5-trifluorophenyl)butanoyl]-3-(trifluoromethyl)-5,6,7,8-tetrahydro-[1,2,4]triazolo[4,3-a]pyrazine
EINECS	Contact for details

Quality Control

Every batch of Sitagliptin Impurity 14 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Our quality assurance protocols are designed to meet the exacting requirements of pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from tests including HPLC purity, identity confirmation (IR, MS), residual solvent analysis, and specific tests for related substances. Our processes support compliance with cGMP and relevant ICH guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.